Diabetes Mellitus Clinical Trial
Official title:
Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of Sanmina Non-invasive Biosensors During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2
Measurement algorithm control and optimization with subsequent performance evaluation of Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type 1 and type 2 diabetes during a standardized meal experiment.
- This study is a combined, open label, prospective, comparative single-center study.
- The study is separated in 3 consecutive study parts. The first 2 study parts include 12
patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2
will be used for optimization and control of the measurement algorithms of the Sanmina
biosensors. During the third study part with enrolment of 36 patients, the precision and
accuracy of the final Sanmina biosensor algorithm will be demonstrated. The study
conduct for all 60 participants of all 3 study parts will be exactly the same. In all
groups of participants, the Sanmina finger clip and wearable non-invasive monitoring
biosensor will be individually introduced and assigned. During the study visit at the
study site, a standardized meal will be given to the participants. At eleven time points
before and after the standardized meal, glucose, heart rate, and pO2 will be measured
using the Sanmina finger clip and wearable non-invasive monitoring biosensor. The
measurement time points are -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The
measurements will be compared to capillary blood glucose measurements by YSI Stat 2300
and StatStrip (glucose), and parallel measurements of the heart rate and the pO2 using a
patient monitor. Further the exact skin colour will be evaluated using a skin colour
card.
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